FDA Approves First Lyrica Generics

FDA Approves First Lyrica Generics

Posted on Jul 23, 2019

The FDA has approved the first generic versions of Lyrica (pregabalin), granting approvals to a total of nine pharmaceutical companies for five different conditions, including the management of neuropathic pain associated with spinal cord injury.

This approval covers a variety of other indications, such as neuropathic pain associated with diabetic peripheral neuropathy, the management of postherpetic neuralgia (shingles pain), use as an adjunctive therapy for the treatment of partial onset seizures in patients aged 17 older, and the management of fibromyalgia.

Pregabalin must be dispensed with a patient Medication Guide that contains important information about its uses and risks. Warnings include the risk of angioedema (swelling of the throat, head and neck), which may be associated with life-threatening respiratory compromise requiring emergency treatment.

Hypersensitivity reactions such as hives, dyspnea (difficulty breathing) and wheezing can occur. Increased seizure frequency or other adverse reactions may occur if the drug is rapidly discontinued. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior.

Additionally, pregabalin may cause peripheral edema (swelling of hands or legs) so caution should be exercised when co-administering it with thiazolidinedione antidiabetic agents. Pregabalin may cause dizziness and drowsiness and impair ability to drive or operate machinery.

The most common side effects reported in the clinical trials for Lyrica in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and abnormal thinking (primarily difficulty with concentration/attention).